510(k) K001993 ยท LFR Glucose Dehydrogenase, Glucose
SOF-TACT DIABETES MANAGEMENT SYSTEM; SOF-TACT GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS
| Applicant | Abbott Laboratories, Bedford MA, US |
| Decision | Substantially Equivalent, Nov 13, 2000 |
| Received | Jun 29, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001993
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.